1. Field of the Invention
The present invention generally relates to dietary supplements for medical patients, and more particularly, to a dietary supplement which is formulated to meet the specific nutrient demands of chemotherapy patients. The dietary supplement includes a palatable composition containing sugars, lipids and amino acids, as well as vitamins and minerals, and can be used as a sole nutrition source for extended periods of time.
2. Description of the Prior Art
Patients diagnosed with cancer usually undergo a treatment plan for curing or managing progression or symptoms of the disease. These treatment plans commonly include surgery, radiation therapy, chemotherapy, hormone therapy, immunotherapy or some combination of these therapies. While the aim of these therapies is to kill cancer cells, some healthy cells also become damaged and killed in the treatment process. The death of healthy cells causes various side effects in cancer patients, such as loss of appetite, weight loss or gain, sore mouth or throat, nausea, and vomiting. These side effects can significantly hinder the cancer patient's ability to eat and assimilate necessary nutrients.
Persons who are healthy generally find it easy to consume the types and quantities of foods required for overall good health. General nutrition guidelines typically stress consumption of large quantities of fruits, vegetables and whole-grain products; moderate quantities of low-fat meat and dairy foods; and low quantities of fat, sugar, alcohol and salt, for optimum health. Patients undergoing chemotherapy treatment, however, may find healthy eating a challenge, due to the many potential adverse side effects of the chemotherapy regimen. For example, the chemotherapy regimen has a tendency to damage the digestive system of the cancer patient, and thus, the supplement or diet must be taken in a form that is easy for the patient to digest. Cancer and cancer treatments may also alter the body's ability to tolerate certain foods and to use nutrients. Consequently, the diet of the cancer patient usually requires significant adjustments in order to enable the patient to withstand the ravages of the disease and the stresses and effects of treatment.
Nutrition programs for cancer patients typically emphasize the consumption of high-calorie, high-protein foods such as milk, cheese and cooked eggs. In the event that the patient suffers excessive weight loss, the patient may be advised to increase consumption of sauces and gravies and to include more butter, margarine, or oil in the patient's diet to increase calorie consumption. The patient may be advised to decrease consumption of high-fiber foods, since these have a tendency to aggravate digestive conditions such as diarrhea.
Adopting a balanced and appropriate nutrition program enables cancer patients to feel better, maintain strength and energy, maintain body weight and store of nutrients, tolerate treatment-related side effects, decrease risk of infection by strengthening the immune system, and expedite healing and recovery. Nutrients that are regarded as essential ingredients of a cancer patient's diet include protein, carbohydrates, fats, vitamins and minerals. Protein helps to ensure growth, repair body tissue, and maintain a healthy immune system. Carbohydrates and fats are needed to supply the body with the bulk of the calories it needs. Vitamins and minerals help ensure proper growth and development and enable the body to use as energy the calories supplied in foods.
A variety of food supplements and diets specifically formulated for athletes, the elderly, pregnant women and other specific groups are known in the art. However, these supplements or diets are generally not suitable for persons afflicted with disease such as HIV, AIDS, short bowel syndrome, Crohn's disease or cancer patients undergoing chemotherapy treatment. Certain common nutrients such as calcium must be excluded from the supplement or diet, since cancer patients tend to accumulate excessively high levels of calcium or the other nutrients. Calcium intolerance associated with chemotherapy precludes patients' use of common commercially available calcium-containing dietary supplements that may otherwise contain the ingredients necessary for proper nutrition of the patient.
Digestive enzymes of the small intestine are embedded within the cell membrane of the microvilli. These enzymes are responsible for the breakdown of large proteins to their basic free amino acid. The enzymes are not secreted in the lumen but remain attached to the cell membrane, with the active site of the enzyme exposed to the chyme. One such brush border enzyme is enterokinase, which is required for the activation of the protein-digesting enzyme, trypsin. Trypsin, which cleaves internal peptide bonds, is also an activator for other enzymes that cause the further digestion of proteins, to the digestion of fatty acids from phospholipids, such as lecithin. Therefore, the intestinal surface area is directly related to the process of digestion. The reduction in epithelial surface area in the small intestines caused by chemotherapy greatly reduces digestion and absorption. This requires nutritional supplements for cancer patients to be easily digestible.
In the digestion of proteins, tripeptides are digested to dipeptides, and the dipeptides are digested to free amino acids. The free amino acids are absorbed into epithelial cells and secreted into the blood. Tripeptides and dipeptides may enter the epithelial cell via other transport carriers, but are further digested to amino acids before they are secreted into the blood. Accordingly, proteins are most easily digested when amino acids are ingested in the free form, preventing the need for further digesting tripeptides and dipeptides into the individual amino acids.
Vitamins are organic molecules that are needed in small amounts in the diet. Humans do not have the capacity to synthesize vitamins, and vitamins must therefore be obtained in the diet. Vitamin A is essential for good vision and healthy skin, hair and mucous membranes of the nose, throat, respiratory system and digestive system. Since the mucous membranes are highly affected by chemotherapy treatment, vitamin A supplementation is of utmost importance to the cancer patient. Vitamin A also stimulates the healing of wounds and is used to treat skin disorders. Beta-carotene, which accumulates in human skin, is a precursor of vitamin A. Excess beta-carotene, along with other carotenoids, acts as an antioxidant and supports immune function to enhance the body's resistance to infections. Vitamin A may help prevent some cancers and vision problems. While vitamin A may be toxic when stored in the body for extended periods of time, beta-carotene is not toxic, even in high doses.
Thiamine, or vitamin B1, is associated with carbohydrate, fat, and protein metabolism. It helps to convert excess glucose into fat and participates in nerve impulse transmission and maintains normal appetite, muscle tone, and mental health. Mild vitamin B1 deficiencies cause fatigue, loss of appetite, nausea, moodiness, confusion, and anemia. Vitamin B5, or pantothenic acid, is required for converting food into energy, building red blood cells, making bile and synthesizing fats, steroids, antibodies and neurotransmitters. Pantothenic acid in lotions and creams reduces the pain of burns, cuts and abrasions, reduces skin inflammation, and speeds wound healing. Vitamin B6 (pyridoxine, pyridoxamine, and pyridoxal) supports the immune system, nerve impulse transmission, energy metabolism, and red blood cell synthesis. Excessive or inadequate levels of vitamin B6 can impair nerve function and mental health. Vitamin B12 (cobalamin), like the other B vitamins, is important for converting fats, carbohydrates, and protein into energy and assisting in the synthesis of red blood cells.
Vitamin C, or ascorbic acid, is known for its ability to prevent and treat scurvy. Connective tissue throughout the body is made of collagen, which depends on vitamin C for its production. In this role, vitamin C helps heal wounds, burns, bruises, and broken bones. As a powerful antioxidant and immune system buster, vitamin C may alleviate the pain of rheumatoid arthritis, protect against arteriosclerosis and heart disease, and help prevent some forms of cancer. Since it is water-soluble, excess vitamin C is excreted in the urine, so large quantities of it may usually be taken without fear of toxicity.
Vitamin D, or cholecalciferol, promotes healthy bones and teeth by regulating the absorption and balance of calcium and phosphorus and fosters normal muscle contraction and nerve function. Supplements of vitamin D may help treat psoriasis and slow or even reverse some cancers such as myeloid leukemia. Vitamin D is fat-soluble; thus, excessive quantities of vitamin D are stored in the body. Because of its potentially toxic effects, vitamin D should not be taken in supplements of more than 400 IU daily unless prescribed by a doctor. The quantities in the current formula of the present invention are reduced to 200 IU (a sum of the recommended five servings a day).
Vitamin E encompasses a family of compounds called tocopherols, of which the alpha tocopherol is the most common. It is required for proper functioning of the immune system, endocrine system, and sex glands. As a powerful antioxidant, vitamin E prevents free radicals from damaging cells and tissues. In this capacity, vitamin E deters atheroscherosis, accelerates the healing of the wounds, protects lung tissue from inhaled pollutants, may reduce risk of heart disease, and may prevent premature skin aging. It is suspected that vitamin E can prevent cancer. Although it is fat soluble, vitamin E is considered nontoxic because it does not cause toxic effects unless administered at very high doses.
Vitamin K (menadione, phytonadione), is required in small but critical quantities to form essential proteins, mainly for blood clotting, but also for kidney function and bone metabolism. Vitamin K exists in two natural forms that require some dietary fat for absorption. Vitamin K is synthesized by intestinal bacteria and released into the intestines for absorption into the bloodstream.
There is an established need for a dietary supplement which is readily available, includes free amino acids for easy digestion, includes vitamins and minerals formulated to meet the nutritional needs of patients undergoing cancer treatment, and which can be used as a sole nutritional source for extended periods of time.